《Implementation_of_QRM_at_Roche_PDA_Dinner_Sept_29-2016 Ram》.pdf

Quality Risk Management Implementation at Roche PDA West Coast Chapter 2011 Professional Dinner Meeting Series Sept 29, 2011 Emma Ramnarine Head, Global QRM, Genentech 1 of 25 Current Status of QRM in the Industry Integrating QRM in the Product Lifecycle Critical success factors 2 Current Status of QRM in the Industry •  QRM is legally enforceable (i.e. EU GMPs) •  ICH Q8, Q9 and Q10 expect: –  QRM application throughout the product and process lifecycle –  Integration of QRM into the Pharmaceutical Quality System (PQS) •  Regulatory agencies focus on use of risk assessments has increased significantly –  Increased use of risk assessments to address inspection observations –  Inspection observations due to inadequate risk management –  Regulators are seeking formal training on QRM –  Increase in risk based regulatory filings (e.g. comparability protocols) 3 QRM Implementation Tools   Typically starts with reactive risk assessments   Level of detail and complexity can vary by company size, but some basic program ) d o should be in place o